Evogen, Inc. — Department of Health and Human Services SBIR Phase I: 106

Description

Project SummaryAbstractEpilepsy affects approximatelyof the world populationtotaling andgtmillion patientsWhile anti epileptic drugAEDtreatment is successful in many patientsof patients continue to experience seizures causing physicians to adjust change medications or other treatment parametersCurrent diagnostic tools are incapable of differentiating between patients experiencing a recent seizure and those who are either seizure free or experiencing non seizure eventsComplicating matterspatients frequently under report seizures in self reported seizure diariesTo aid physicians in assessing the current state of seizure control in epilepsy patientsEvogen is developing a diagnostic test to distinguish epilepsy patients who have recently experienced a seizure from those who have notTowards developing this testEvogen has identified and patented a unique combination ofproteins that stratify actively seizing patients from those who have not experienced a recent seizureTo confirm the previous resultsEvogen will first measure the plasma levels oftarget proteins in powered cohorts of patients using validated ELISA run on the Meso Scale Discovery platformMean protein concentration will be calculated and cohorts compared to determine if significant differences existSubsequentlywe will combine thetarget protein levels into a diagnostic algorithmtoward the goal of achieving a diagnostic output of a singleseizure probability scoreWe recognize that ideal diagnostic results are concise and simpleideally just one number or a yes noso a physician can quickly interpret and appropriately actBoth descriptive statistic results and algorithm performance will be used to determine the success of this effortThe test will have a profound impact on diagnosis and treatment of epilepsyFuture applications to support patient care throughout the life of the patient include identifying initial seizures and identifying potential refractory patientsAlsothe test will serve to bolster drug development and clinical trial success by ensuring the right types of patients are enrolled and provide an objective clinical endpoint Project Narrative Epilepsy actively affects approximatelyof the world populationtotalingmillion patientsCurrent tools to diagnosis if epileptic patients recently had a seizure have limited performancehigh costs and limited availabilityA diagnostic test that indicates if a patient recently experienced a seizure would provide physicians with objectiveactionable data that can result in improved clinical carepatient outcomes and healthcare system savings